SQR:

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide

Your role:

As Manager, Quality Management, you will build and lead the hosted Quality Management team based at our Global Business Services (GBS) campus in Bangalore. You will be accountable for quality deliverables across Fresenius Medical Care’s global product portfolio as a full member of the global SQR team.
• Build, lead and develop a high-performing Quality Management team – recruitment, onboarding, coaching,



performance management and succession planning, in partnership with global SQR leadership and GBS enabling functions
• Hold end-to-end accountability for quality deliverables as an integral part of the global and regional Quality teams: controlled document management, supplier quality, quality data and KPI reporting, learning and training compliance, and support for clinical evaluation and post-market documentation
• Own document control processes – authoring, review, approval and maintenance of SOPs, work instructions and controlled records – ensuring compliance with ISO 13485, 21 CFR Parts 820/QMSR and applicable regional QMS requirements
• Support supplier quality management: supplier qualification and performance monitoring, quality agreements, non-conformance handling and supplier CAPA follow-up
• Support execution of CAPA, non-conformance and complaint-handling activities, assessing quality impa

📌 Qa Lead Regulatory Affairs, Sqr Bengaluru
🏢 Fresenius Medical Care
📍 Bengaluru